Name: Predicase
Price: 199 USD

K-number	K150969
Device name	Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
Applicant	Karl Storz Endoscopy America, Inc.
Product code	ERL
Device class	Class II
Decision date	Jan 8, 2016
Decision	Substantially Equivalent
Regulation	874.4250

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Source

View the full FDA submission: accessdata.fda.gov

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Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Everything you need for a 510(k) submission. Nothing you don't.